Meaningful use regulations for recovery audit contractors

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this technology, they will de- mand nothing less from their providers. Hundreds of thousands of physicians have already seen these benefits in their clinical practice.

But inevitability does not mean easy transition. We have years of professional agreement and bipar- tisan consensus regarding the potential value of EHRs. Yet we have not moved significantly to extend the availability of EHRs from a few large institutions to the smaller clinics and practices where most Americans receive their health care.

Last year, Congress and the Obama administration provided the health care community with a transformational opportunity to

break through the barriers to progress. The Health Information Technology for Economic and Clinical Health Act (HITECH) authorized incentive payments through Medicare and Medicaid to clinicians and hospitals when they use EHRs privately and se- curely to achieve specified im- provements in care delivery.

Through HITECH, the federal government will commit unprece- dented resources to supporting the adoption and use of EHRs. It will make available incentive pay- ments totaling up to $27 billion over 10 years, or as much as $44,000 (through Medicare) and $63,750 (through Medicaid) per clinician. This funding will pro- vide important support to achieve

liftoff for the creation of a nation- wide system of EHRs.

Equally important, HITECH’s goal is not adoption alone but “meaningful use” of EHRs — that is, their use by providers to achieve significant improvements in care. The legislation ties pay- ments specifically to the achieve- ment of advances in health care processes and outcomes.

HITECH calls on the secretary of health and human services to develop specific “meaningful use” objectives. With the Centers for Medicare and Medicaid Services (CMS) in the lead, the Department of Health and Human Services (DHHS) has used an inclusive and open process to develop these criteria, providing an extensive opportunity for public and pro- fessional input. The department published proposed meaningful use requirements on January 16, 2010. The proposal prompted some 2000 comments. This week, the

The “Meaningful Use” Regulation for Electronic Health Records David Blumenthal, M.D., M.P.P., and Marilyn Tavenner, R.N., M.H.A.

The widespread use of electronic health records (EHRs) in the United States is inevitable. EHRs will improve caregivers’ decisions and patients’ out- comes. Once patients experience the benefits of

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DHHS is releasing a final regu- lation for the first 2 years (2011 and 2012) of this multiyear in- centive program. Subsequent rules will govern later phases.

Although the intent of our Jan- uary proposals has been retained and indeed affirmed through the rule-making process, the final regulation also incorporates sig- nificant changes — a response to the comments and experience that diverse stakeholders shared with us. In particular, concerns about the pace and scope of im-

plementation of meaningful use led us to adopt a two-track ap- proach regarding the objectives that allow practices and hospitals to qualify for incentive payments in the first 2 years of the program.

The most important part of this regulation is what it says hospitals and clinicians must do with EHRs to be considered meaningful users in 2011 and 2012. In the original proposal, we identified a broad set of ob- jectives, all of which would need to be met. This included 23 ob-

jectives for hospitals and 25 for clinicians. The DHHS received many comments that this ap- proach was too demanding and inf lexible, an all-or-nothing test that too few providers would be likely to pass.

In the final regulation, we have divided these elements into two groups: a set of core objec- tives that constitute an essential starting point for meaningful use of EHRs and a separate menu of additional important activities from which providers

“Meaningful Use” Regulation for Ehrs

Summary Overview of Meaningful Use Objectives.*

Objective Measure

Core set of objectives to be achieved by all eligible professionals, hospitals, and critical access hospitals to qualify for incentive payments

Record patient demographics (sex, race, ethnicity, date of birth, preferred language, and in the case of hospitals, date and preliminary cause in the event of death)

Over 50% of patients’ demographic data recorded as structured data

Record vital signs and chart changes (height, weight, blood pres- sure, body-mass index, growth charts for children)

Over 50% of patients 2 years of age or older have height, weight, and blood pressure recorded as structured data

Maintain up-to-date problem list of current and active diagnoses Over 80% of patients have at least one entry recorded as structured data

Maintain active medication list Over 80% of patients have at least one entry recorded as structured data

Maintain active medication allergy list Over 80% of patients have at least one entry recorded as structured data

Record smoking status for patients 13 years of age or older Over 50% of patients 13 years of age or older have smoking status recorded as structured data

For individual professionals, provide patients with clinical sum- maries for each office visit; for hospitals, provide an electronic copy of hospital discharge instructions on request

Clinical summaries provided to patients for over 50% of all office vis- its within 3 business days; over 50% of all patients who are discharged from the inpatient department or emergency department of an eligible hospital or critical access hospital and who request an electronic copy of their discharge instructions are provided with it

On request, provide patients with an electronic copy of their health information (including diagnostic-test results, problem list, medi- cation lists, medication allergies, and for hospitals, discharge summary and procedures)

Over 50% of requesting patients receive electronic copy within 3 business days

Generate and transmit permissible prescriptions electronically (does not apply to hospitals)

Over 40% are transmitted electronically using certified EHR technology

Computer provider order entry (CPOE) for medication orders Over 30% of patients with at least one medication in their medica- tion list have at least one medication ordered through CPOE

Implement drug–drug and drug–allergy interaction checks Functionality is enabled for these checks for the entire reporting period

Implement capability to electronically exchange key clinical infor- mation among providers and patient-authorized entities

Perform at least one test of EHR’s capacity to electronically ex- change information

Implement one clinical decision support rule and ability to track compliance with the rule

One clinical decision support rule implemented

Implement systems to protect privacy and security of patient data in the EHR

Conduct or review a security risk analysis, implement security up- dates as necessary, and correct identified security deficiencies

Report clinical quality measures to CMS or states For 2011, provide aggregate numerator and denominator through attestation; for 2012, electronically submit measures

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“Meaningful Use” Regulation for Ehrs

will choose several to implement in the first 2 years (see table).

Core objectives comprise ba- sic functions that enable EHRs to support improved health care. As a start, these include the tasks essential to creating any medical record, including the entry of basic data: patients’ vital signs and demographics, active medi- cations and allergies, up-to-date problem lists of current and active diagnoses, and smoking status.

Other core objectives include

using several software applica- tions that begin to realize the true potential of EHRs to im- prove the safety, quality, and ef- ficiency of care. These features help clinicians to make better clinical decisions — and avoid preventable errors. To qualify for incentive payments, clinicians must start employing such clini- cal decision support tools. They must also start using the capa- bility that undergirds much of the value of EHRs: using records

to enter clinical orders and, in particular, medication prescrip- tions. Only when providers enter orders electronically can the com- puter help improve decisions by applying clinical logic to those choices in light of all the record- ed patient data. And to begin extending the benefits of EHRs to patients themselves, the mean- ingful use requirements will in- clude providing patients with elec- tronic versions of their health information.

Summary Overview of Meaningful Use Objectives (Continued.)

Objective Measure

Eligible professionals, hospitals, and critical access hospitals may select any five choices from the menu set

Implement drug formulary checks Drug formulary check system is implemented and has access to at least one internal or external drug formulary for the entire reporting period

Incorporate clinical laboratory test results into EHRs as structured data

Over 40% of clinical laboratory test results whose results are in positive/ negative or numerical format are incorporated into EHRs as struc- tured data

Generate lists of patients by specific conditions to use for quality improvement, reduction of disparities, research, or outreach

Generate at least one listing of patients with a specific condition

Use EHR technology to identify patient-specific education re- sources and provide those to the patient as appropriate

Over 10% of patients are provided patient-specific education re- sources

Perform medication reconciliation between care settings Medication reconciliation is performed for over 50% of transitions of care

Provide summary of care record for patients referred or transi- tioned to another provider or setting

Summary of care record is provided for over 50% of patient transi- tions or referrals

Submit electronic immunization data to immunization registries or immunization information systems

Perform at least one test of data submission and follow-up submis- sion (where registries can accept electronic submissions)

Submit electronic syndromic surveillance data to public health agencies

Perform at least one test of data submission and follow-up submission (where public health agencies can accept electronic data)

Additional choices for hospitals and critical access hospitals

Record advance directives for patients 65 years of age or older Over 50% of patients 65 years of age or older have an indication of an advance-directive status recorded

Submit electronic data on reportable laboratory results to public health agencies

Perform at least one test of data submission and follow-up submis- sion (where public health agencies can accept electronic data)

Additional choices for eligible professionals

Send reminders to patients (per patient preference) for pre ventive and follow-up care

Over 20% of patients 65 years of age or older or 5 years of age or younger are sent appropriate reminders

Provide patients with timely electronic access to their health information (including laboratory results, problem list, medication lists, medication allergies)

Over 10% of patients are provided electronic access to information within 4 days of its being updated in the EHR

* This overview is meant to provide a reference tool indicating the key elements of meaningful use of health information technology. It does not provide sufficient information for providers to document and demonstrate meaningful use in order to obtain financial incentives from the Centers for Medicare and Medicaid Services (CMS). The regulations and filing requirements that must be fulfilled to qualify for the Health IT financial incentive program are detailed at www.cms.gov.

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In addition to the core ele- ments, the rule creates a second group: a menu of 10 additional tasks, from which providers can choose any 5 to implement in 2011–2012. This gives providers latitude to pick their own path toward full EHR implementation and meaningful use.

For example, the menu in- cludes capacities to perform drug- formulary checks, incorporate clinical laboratory results into EHRs, provide reminders to pa- tients for needed care, identify and provide patient-specific health education resources, and employ EHRs to support the patient’s transitions between care settings or personnel.

For most of the core and menu items, the regulation also specifies the rates at which pro- viders will have to use particular functions to be considered mean- ingful users. Reflecting the views and experiences shared during the comment period, these rates will enable significant progress toward improving care — but are also achievable by average practices and providers in the early years.

The HITECH legislation further requires that meaningful use in- clude electronic reporting of data on the quality of care. In the final regulation, we have simplified the January proposals for quality re- porting, while still building to- ward a robust reporting capabil- ity that will inform providers about their own performance and

will eventually inform the public as well. Clinicians will have to report data on three core quality measures in 2011 and 2012: blood-pressure level, tobacco sta- tus, and adult weight screening and follow-up (or alternates if these do not apply). Clinicians must also choose three other measures from lists of metrics that are ready for incorporation into electronic records.

The meaningful use rule is part of a coordinated set of reg- ulations to help create a private and secure 21st-century electron- ic health information system. On June 18, 2010, the DHHS issued a rule that laid out a process for the certification of electronic health records, so that providers can be assured they are capable of meaningful use. The depart- ment has also issued still anoth- er regulation that lays out the standards and certification cri- teria that EHRs must meet in order to be certified. Finally, re- alizing that the privacy and se- curity of EHRs are vital, the DHHS has been working hard to safeguard privacy and security by implementing new protections contained in the HITECH legis- lation.

The meaningful use rule strikes a balance between acknowledg- ing the urgency of adopting EHRs to improve our health care sys- tem and recognizing the chal- lenges that adoption will pose to health care providers. The reg- ulation must be both ambitious

and achievable. Like an escala- tor, HITECH attempts to move the health system upward toward improved quality and effective- ness in health care. But the speed of ascent must be calibrated to ref lect both the capacities of providers who face a multitude of real-world challenges and the maturity of the technology itself.

As part of this process, the DHHS is establishing a nation- wide network of Regional Exten- sion Centers to assist providers in adopting qualified EHRs and making meaningful use of them. The DHHS is committed to the support, collaboration, and on- going learning that will mark our progress toward electronically con- nected, information-driven med- ical care. We hope that providers and consumers will now join us in the effort to assure that we make the best possible use of our most precious health care resource: information about the patients we serve.

Disclosure forms provided by the au- thors are available with the full text of this article at NEJM.org.

Dr. Blumenthal is the national coordinator for health information technology at the Department of Health and Human Ser- vices, and Ms. Tavenner is the principal deputy administrator of the Centers for Medicare and Medicaid Services — both in Washington, DC.

This article (10.1056/NEJMp1006114) was published on July 13, 2010, at NEJM.org.

Copyright © 2010 Massachusetts Medical Society.

“Meaningful Use” Regulation for Ehrs

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